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Alexion Soliris Fails in Phase II/III Delayed Graft Function Study
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Alexion Pharmaceuticals, Inc. announced that Soliris has failed to meet the primary endpoint in a randomized, parallel-group, double-blind, placebo-controlled, multi-center phase II/III study (PROTECT).
We expect investors to react negatively to the news. Alexion’s year-to-date share price movement shows that the stock has underperformed the Zacks classified Medical - Biomedical and Genetics industry. Specifically, Alexion has plunged 37.6% during this period, while the industry lost 25.3%.
Shares of Alexion have been under pressure of late, given the sudden departure of its key executives in the middle of an ongoing internal investigation into the sales practices related to Soliris. This sales probe led to a delay in the filing of the company’s Form 10-Q for the period ended Sep 30, 2016. It now expects to file the 10-Q in Jan 2017 or earlier. Naturally, the recent label expansion setback related to Soliris isn’t helping matters in any way.
Coming back to the news, Soliris was administered in an acute setting in the study for the prevention of delayed graft function (DGF) in adult recipients of a deceased-donor kidney transplant who are at increased risk of the disease.
Data revealed that the primary endpoint of incidence of DGF with a two-dose regimen of Soliris in comparison to placebo failed to attain statistical significance. The primary endpoint also included the incidence of death, graft loss and loss to follow-up including discontinuation, which was 35.9% for patients receiving a two-dose regimen of Soliris in comparison to 41.7% for patients in the placebo arm. However, Soliris demonstrated a favorable safety profile.
Alexion stated in the press release that it will continue to analyze the data to facilitate understanding of the findings for patients undergoing kidney transplant. The company anticipates publication of the study data at a later date.
Nevertheless, the study results are far from impressive. Per the company’s press release, DGF is an early and serious complication of organ transplantation, affecting around 25–50% of deceased-donor kidney transplant cases, in which the transplanted organ fails to function normally following transplantation.
Note that Alexion was looking to increase the commercial potential of Soliris by expanding the drug’s label to include this indication. Considering that there is no approved treatment for this serious and life-threatening complication, successful development of Soliris would have added to the drug’s sales.
Soliris had been granted Orphan Drug designation for the prevention of DGF in renal transplant patients in the U.S., and for the prevention of DGF after solid organ transplantation in the EU.
We note that Soliris is a key growth driver at Alexion and is approved for the treatment of two life-threatening ultra-rare disorders – paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. The drug raked in sales of $2.1 billion in the first nine months of 2016.
Alexion is also developing Soliris for the treatment of patients with refractory generalized myasthenia gravis and relapsing neuromyelitis optica spectrum disorder.
Alexion currently carries a Zacks Rank #5 (Strong Sell). Some better-ranked stocks in this industry include Arbutus Biopharma Corporation (ABUS - Free Report) , Athersys, Inc. and MannKind Corporation (MNKD - Free Report) . All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Athersys’ loss estimates narrowed from 23 cents to 18 cents for 2016 while that for 2017 remained unchanged over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 110.52%. Its share price has gained 53.4% year to date.
Arbutus’ loss estimates narrowed from $2.15 to $1.71 for 2016 and from $1.96 to $1.46 for 2017 over the last 60 days. The company posted positive surprises thrice in the four trailing quarters with an average beat of 59.31%.
MannKind’s estimates narrowed from loss of 24 cents to earnings of 12 cents for 2016 over the last 60 days. For 2017, loss estimates narrowed from 14 cents to 9 cents over this period. The company posted a positive surprise in two of the four trailing quarters with an average beat of 103.33%.
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Alexion Soliris Fails in Phase II/III Delayed Graft Function Study
Alexion Pharmaceuticals, Inc. announced that Soliris has failed to meet the primary endpoint in a randomized, parallel-group, double-blind, placebo-controlled, multi-center phase II/III study (PROTECT).
We expect investors to react negatively to the news. Alexion’s year-to-date share price movement shows that the stock has underperformed the Zacks classified Medical - Biomedical and Genetics industry. Specifically, Alexion has plunged 37.6% during this period, while the industry lost 25.3%.
Shares of Alexion have been under pressure of late, given the sudden departure of its key executives in the middle of an ongoing internal investigation into the sales practices related to Soliris. This sales probe led to a delay in the filing of the company’s Form 10-Q for the period ended Sep 30, 2016. It now expects to file the 10-Q in Jan 2017 or earlier. Naturally, the recent label expansion setback related to Soliris isn’t helping matters in any way.
Coming back to the news, Soliris was administered in an acute setting in the study for the prevention of delayed graft function (DGF) in adult recipients of a deceased-donor kidney transplant who are at increased risk of the disease.
Data revealed that the primary endpoint of incidence of DGF with a two-dose regimen of Soliris in comparison to placebo failed to attain statistical significance. The primary endpoint also included the incidence of death, graft loss and loss to follow-up including discontinuation, which was 35.9% for patients receiving a two-dose regimen of Soliris in comparison to 41.7% for patients in the placebo arm. However, Soliris demonstrated a favorable safety profile.
Alexion stated in the press release that it will continue to analyze the data to facilitate understanding of the findings for patients undergoing kidney transplant. The company anticipates publication of the study data at a later date.
Nevertheless, the study results are far from impressive. Per the company’s press release, DGF is an early and serious complication of organ transplantation, affecting around 25–50% of deceased-donor kidney transplant cases, in which the transplanted organ fails to function normally following transplantation.
Note that Alexion was looking to increase the commercial potential of Soliris by expanding the drug’s label to include this indication. Considering that there is no approved treatment for this serious and life-threatening complication, successful development of Soliris would have added to the drug’s sales.
Soliris had been granted Orphan Drug designation for the prevention of DGF in renal transplant patients in the U.S., and for the prevention of DGF after solid organ transplantation in the EU.
We note that Soliris is a key growth driver at Alexion and is approved for the treatment of two life-threatening ultra-rare disorders – paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. The drug raked in sales of $2.1 billion in the first nine months of 2016.
Alexion is also developing Soliris for the treatment of patients with refractory generalized myasthenia gravis and relapsing neuromyelitis optica spectrum disorder.
ALEXION PHARMA Price and Consensus
ALEXION PHARMA Price and Consensus | ALEXION PHARMA Quote
Zacks Rank & Key Picks
Alexion currently carries a Zacks Rank #5 (Strong Sell). Some better-ranked stocks in this industry include Arbutus Biopharma Corporation (ABUS - Free Report) , Athersys, Inc. and MannKind Corporation (MNKD - Free Report) . All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Athersys’ loss estimates narrowed from 23 cents to 18 cents for 2016 while that for 2017 remained unchanged over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 110.52%. Its share price has gained 53.4% year to date.
Arbutus’ loss estimates narrowed from $2.15 to $1.71 for 2016 and from $1.96 to $1.46 for 2017 over the last 60 days. The company posted positive surprises thrice in the four trailing quarters with an average beat of 59.31%.
MannKind’s estimates narrowed from loss of 24 cents to earnings of 12 cents for 2016 over the last 60 days. For 2017, loss estimates narrowed from 14 cents to 9 cents over this period. The company posted a positive surprise in two of the four trailing quarters with an average beat of 103.33%.
The Best Place to Start Your Stock Search
Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>